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Stress Study Lands Colonel in Hot Water


Atlanta Journal Constitution | By Alison Young | September 03, 2007

As a combat surgeon in Afghanistan, Col. Richard Gonzalez earned a Bronze Star and Army accolades for his self-sacrifice.

Now Gonzalez is fighting to save his military career, accused of discrediting his uniform as leader of a scientific study at Fort Benning.

The Army has halted the study, which was examining the debilitating impact of stress on recruits, and ordered results kept secret.

Gonzalez was demoted and is under investigation for arranging a researcher's no-bid contract and conducting an unapproved study. The Army is also looking into possible violations of consent and medical privacy procedures.

But Army documents show the research board that first approved the study --- and is now investigating Gonzalez's team --- shares blame for miscommunications and mistakes.

The board did not explain study requirements or properly supervise Gonzalez, a first-time researcher, an Army audit found. Nor did it forward his proposal for a required command-level review. The board even lost track of what study plan it had approved.

Shutting down the study may have violated soldiers' trust in more fundamental ways. Each of the 330 recruits volunteered on the promise that the project might save others from physical and mental injuries. They spent hours sharing intimate details about the most stressful events of their lives.

In the wake of the investigations, without Gonzalez's knowledge, the Army removed the recruits' private files so it could turn his locked study office into an employee break room.

While Gonzalez later found paper files in a "disheveled" state, the Army wouldn't tell him where the study's computer was, records show.

The incident has raised serious questions among researchers about whether intensely private details --- such as recruits' accounts of childhood abuse and molestation --- have been disclosed.

Several Army commanders, citing ongoing investigations, declined requests for interviews. An Army spokeswoman said the files and computer are secure.

While blame is heaped upon Gonzalez, others are avoiding responsibility, a researcher said.

"We're the fall guys," said Roger Bannon, a retired Army major and Gonzalez's study manager until he was fired in July.

"The easiest thing for them to do," Bannon said, "is to pick the weakest target at the lowest level and that's Colonel Gonzalez and me." Proposal impressed CDC

Many thought the study held great promise when Gonzalez pitched it. The idea drew support from top scientists at the Centers for Disease Control and Prevention and won $250,000 in an Army research competition.

"Dr. Gonzalez' study is one of the best organized [conceptually and operationally] that I have been privileged to collaborate on," the CDC's Dr. William Reeves wrote this summer to Gonzalez's commanders.

In Afghanistan, Gonzalez had seen constant fatigue among Soldiers. He saw the same fatigue among recruits when he returned to Fort Benning, he said last fall in an Atlanta Journal-Constitution interview.

"I wanted to look at Soldiers from the beginning, wondering about stress-related problems," he said. Gonzalez wondered if he could predict which Soldiers would break down from injuries, fatigue or post-traumatic stress disorder.

Up to 15 percent of recruits don't complete basic training, a problem as the Army struggles with enlistment goals. And veterans are grappling with high rates of PTSD.

Gonzalez's commander named Bannon as his study manager, even though Bannon also had no research experience. Reeves and his CDC team joined the project after the researchers came across his work on the role stress plays in chronic fatigue and Gulf War syndrome. CDC declined interview requests.

All seemed well after the study began last September. But an Oct. 16 feature article in the Army Times sparked a cascade of questions from the Army's surgeon general and others who had been unaware of the project, e-mails show.

It turned out the Army had never fully approved the study. An Army institutional review board in Augusta had signed off on the proposal but failed to forward it for a required higher-level approval, records show. Institutional review boards scrutinize plans for a study to ensure rules are followed and research subjects are protected.

IRB approval is usually all that's required in the civilian world. The Army requires a second approval to protect Soldiers from being coerced into research. The study later got that second approval, but researchers hit a new snag in May. An Army research expert discovered Gonzalez's team had taken blood samples before recruits signed consent forms. Fort Benning, as part of a mandatory intake process, already takes blood from every recruit. The researchers had them collect a little extra for their study.

Researchers only analyzed the blood if a Soldier later signed a consent form. But the adviser said consent must be obtained before blood is taken. In the civilian world, this is not a major breach because the blood was not tested without consent, bioethicists said. "It doesn't constitute research at that point," said David Magnus, director of the Stanford Center for Biomedical Ethics.

The IRB and the higher-level review office hadn't caught the problem because the researchers said consent would be obtained prior to any study procedures, Army officials said in a statement.

Richard Topolski, an Augusta State University professor and member of the research team, said in hindsight the study's protocol was not clear. But there was no intent to mislead, said Topolski. Researchers wanted to eliminate the minor risk of a second needle-stick, he said. Contract scrutinized

Still, e-mails show the second phase of the study involving 1,200 recruits seemed to be on track for a June 20 launch, when the commander of Fort Benning's hospital abruptly halted the project May 30.

Col. Margaret Rivera ordered Gonzalez and Bannon to report on their preliminary findings and provide a financial audit and a copy of Bannon's contract. Bannon retired May 1 from the Army but continued work under a $72,000 contract.

With no experience with contracting, Bannon said he and Gonzalez relied heavily on Fort Benning procurement officials who told them it would be OK to give a sole-source contract to a Virginia firm that then hired Bannon.

"If they told me I wasn't allowed to do this, then I never would have done that," said Bannon, an occupational therapist. But Rivera's staff concluded the researchers began the study without proper approval and had made misleading statements to get Bannon's contract.

The Army canceled the contract and is considering legal action against Bannon. Gonzalez, once the hospital's chief of warrior care and chief of orthopedics, was demoted to staff doctor. Fort Benning's commander, Maj. Gen. Walter Wojdakowski, on July 26 reprimanded Gonzalez, saying his actions "demonstrate a complete lack of judgment and bring discredit upon you, your unit, and the United States Army."

Gonzalez, who was touted by Army publicists in 2004 for volunteering for an extra year in Afghanistan, is close to qualifying for military retirement benefits. He sold his private surgery practice and converted from a National Guard officer to active duty Army while in Afghanistan. Bannon said he fears the Army is laying the groundwork to discharge Gonzalez and leave him with nothing.

Christopher Yukins, a government contract law expert at George Washington University, said departing government employees are supposed to be briefed on rules for future employment. And he said prudent contractors will often ask an incoming employee for an ethics letter from the government saying a contract job is OK.

Neither happened, Bannon said. Data remain unpublished

While Bannon and Gonzalez admit mistakes, an audit by the Army's Clinical Investigation Regulatory Office in July also blamed the IRB for not monitoring the study properly.

The audit also called for the Fort Benning data to be analyzed and put to use if it will help Soldiers. But the IRB continues to tell the researchers they may not publish the data.

It's put CDC's scientists in a bind: They have a manuscript they want to send to a journal and still want to continue the research.

Army officials would not say whether disciplinary action was taken against the IRB or its chairman, Lt. Col. Joseph Wood.

"Any communication and procedural problems from the IRB have been recognized and are corrected," the Army said.

Since June, Bannon has asked the Defense Department's inspector general, the Government Accountability Office and U.S. Rep. Sanford Bishop (D-Ga.) for an independent investigation.

So far, he said, nobody's taken up the probe.

Staff writer Bill Hendrick contributed to this article.

 


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